PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)

NCT00774566 | Completed Phase 4 Results

• 1 other identifier: SKK-001
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to the standard ablation technique (segmental isolation of the pulmonary veins) with radiofrequency energy. The primary study aim is to investigate whether the new cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of atrial arrhythmias without persistent complications after six and twelve months. Furthermore, the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during the procedure, levels of cardiac inflammatory markers are compared between the treatment groups. The short and long-term clinical success as well as the costs of both systems will also be evaluated.

Conditions

Atrial Fibrillation

Keywords

catheter ablation; randomized; cryo; radiofrequency; atrial fibrillation; cryo-balloon; PV-Isolation

Outcome Measures

Primary Outcomes (2)

• Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications at Six Months After the Index Procedure

  Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.

  Six months after procedure

• Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications Twelve Months After Procedure.

  Including redo procedures. Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.

  Twelve month after the procedure

Secondary Outcomes (5)

• Long-term Clinical Success

  Twelve month after the procedure

• Total Radiation Exposure

  at time of the procedure

• Total Procedure Duration

  at time of the procedure

• Major Adverse Events

  procedure date till 12 month after the procedure

• Mid-term Clinical Success

  Six month after the procedure

Study Arms (2)

1

ACTIVE COMPARATOR

segmental PVI using an irrigated tip catheter

Procedure: PV-Isolation RF

2

ACTIVE COMPARATOR

PVI using the Cryo-Balloon

Procedure: PV-Isolation Cryo

Interventions

PV-Isolation RF PROCEDURE

Radiofrequency

Also known as: RF

1

PV-Isolation Cryo PROCEDURE

Cryo-Balloon

Also known as: Cryo

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months, at least 1 episode of PAF must be documented.
• Age 18-75
• Documented effectiveness failure of at least 1 AAD including beta-blockers

You may not qualify if:

• AAD usage \< 3 half life periods (except beta-blocker)
• LA size \> 55 mm
• LA thrombus
• Previous LA ablation/surgery, structural heart disease, heart failure class III-IV
• Hypertrophic cardiomyopathy
• Mitral prosthesis
• Unstable angina
• Uncontrolled hyperthyroidism
• Stroke or TIA within 6 months
• Myocardial infarction within 2 months
• Cardiac surgery within 3 months
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• EF \< 40%
• Pregnancy

Sponsors & Collaborators

• Staedtisches Klinikum Karlsruhe: lead
• Heidelberg University: collaborator

Study Sites (1)

Staedtisches Klinikum

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Related Publications (2)

• Neumann T, Vogt J, Schumacher B, Dorszewski A, Kuniss M, Neuser H, Kurzidim K, Berkowitsch A, Koller M, Heintze J, Scholz U, Wetzel U, Schneider MA, Horstkotte D, Hamm CW, Pitschner HF. Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study. J Am Coll Cardiol. 2008 Jul 22;52(4):273-8. doi: 10.1016/j.jacc.2008.04.021.

  PMID: 18634982 RESULT

• Luik A, Kunzmann K, Hormann P, Schmidt K, Radzewitz A, Bramlage P, Schenk T, Schymik G, Merkel M, Kieser M, Schmitt C. Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes. BMC Cardiovasc Disord. 2017 May 25;17(1):135. doi: 10.1186/s12872-017-0566-6.

  PMID: 28545407 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Armin Luik
• Organization: Stardtisches Klinikum Karlsruhe, Medizinische Klinik IV

armin.luik@klinikum-karlsruhe.de

0049-721974

Study Officials

• Claus Schmitt, MD

  Staedtisches Klinikum Karlsruhe

  STUDY CHAIR

• Armin Luik, MD

  Staedtisches Klinikum Karlsruhe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Armin Luik

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 6, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-03

Locations

DE (1)